Recall Z-0761-2020 ยท MMI Immunoassay Method, Troponin Subunit
Abbott Point Of Care Inc.
i-STAT cTnI cartridge
| Date | Oct 16, 2019 |
| Status | Terminated |
| Reason | i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range. |
| Root cause | Device Design |
| Action | On October 16, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail. It explains Abbott Point of Care has made the decision to transition U.S. customers using the i-STAT cTnI blue cartridge, list number 06P23-25, to the i-STAT cTnI white cartridge, list number 03P90-25, beginning in November 2019. The i-STAT cTnI blue cartridge, list number 06P23-25, will be discontinued for sale in the United States as of January 1, 2020. It further explains to customers while the i-STAT cTnI blue cartridges can continue to be used for patient testing, APOC recommends that a |
| Quantity | 3,465,875 |
| Distribution | US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY |
| FDA record | Open on fda.gov |